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According to the results of the adverse drug reaction assessment, in order to further protect the safety of public drug use, the State Medical Products Administration decided to uniformly revise
the warning words and [adverse reactions], [contraindications] and [precautions] in the instructions of astragalus polysaccharides for injection, sodium chloride injection and banlangen injection.
The relevant matters are hereby announced as follows:
the warning words and [adverse reactions], [contraindications] and [precautions] in the instructions of astragalus polysaccharides for injection, sodium chloride injection and banlangen injection.
The relevant matters are hereby announced as follows:
1.
The marketing authorization holders of all the above-mentioned drugs shall amend the instructions in accordance with the relevant provisions of the Measures for the Administration of Drug Registration and other relevant provisions, and submit them to the provincial drug regulatory authorities for the record
before January 27, 2023.
The marketing authorization holders of all the above-mentioned drugs shall amend the instructions in accordance with the relevant provisions of the Measures for the Administration of Drug Registration and other relevant provisions, and submit them to the provincial drug regulatory authorities for the record
before January 27, 2023.
Where the content of the amendment involves drug labels, it shall be revised together; The instruction manual and other contents of the label shall be consistent
with the original approved content.
Drugs produced from the date of filing shall not continue to use the original drug instructions
.
The MAH shall replace
the instructions and labels of the drugs that have left the factory within 9 months after filing.
with the original approved content.
Drugs produced from the date of filing shall not continue to use the original drug instructions
.
The MAH shall replace
the instructions and labels of the drugs that have left the factory within 9 months after filing.
2.
Drug marketing authorization holders shall conduct in-depth research on the mechanism of new adverse reactions, take effective measures to publicize and train on drug use and safety issues, and guide physicians, pharmacists and patients in rational drug use
.
Drug marketing authorization holders shall conduct in-depth research on the mechanism of new adverse reactions, take effective measures to publicize and train on drug use and safety issues, and guide physicians, pharmacists and patients in rational drug use
.
3.
Clinicians and pharmacists should carefully read the revised content of the above drug instructions, and when selecting drugs, they should conduct a full benefit/risk analysis
according to the newly revised instructions.
Clinicians and pharmacists should carefully read the revised content of the above drug instructions, and when selecting drugs, they should conduct a full benefit/risk analysis
according to the newly revised instructions.
4.
Patients should carefully read the drug instructions before taking medication, and should strictly follow the doctor's advice when using prescription drugs
.
Patients should carefully read the drug instructions before taking medication, and should strictly follow the doctor's advice when using prescription drugs
.
5.
The provincial-level drug regulatory departments shall promptly urge the drug marketing authorization holders of the above-mentioned drugs within the administrative region to complete the revision of the corresponding instructions and the replacement of labels and instructions as required, and strictly investigate and deal with violations of laws and
regulations in accordance with law.
The provincial-level drug regulatory departments shall promptly urge the drug marketing authorization holders of the above-mentioned drugs within the administrative region to complete the revision of the corresponding instructions and the replacement of labels and instructions as required, and strictly investigate and deal with violations of laws and
regulations in accordance with law.
This is hereby announced
.
.
Attachments: 1.
Astragalus polysaccharide for injection instructions revision requirements
Astragalus polysaccharide for injection instructions revision requirements
2.
Revision requirements for the instruction manual of scapsulin sodium chloride injection
Revision requirements for the instruction manual of scapsulin sodium chloride injection
3.
Banlangen injection manual revision requirements
Banlangen injection manual revision requirements
NMPA
October 28, 2022
